Anethesia Efficacy on Teeth With MIH (Molar Incisor Hypomineralisation)

NCT05344014 | Completed

• 1 other identifier: KAEK/04.bI.05
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Difficulty in achieving anesthesia in teeth with molar incisor hypomineralisation (MIH) is a frequently reported clinical problem. The effect of low-level laser on the efficacy of anesthesia in teeth with MIH has not been studied yet. Aim of this study is to evaluate the effect of the Photobiomodulation on the efficacy of anesthesia of maxillary permanent molar teeth with MIH. Design: The current study was conducted as a prospective, parallel-arm control, randomized, triple-blind clinical trial in children aged between 7to12 years. Maxillary permanent molar teeth with MIH requiring pulpotomy treatment were included. 70 participants were divided randomly into 2 groups as experiment (with PBMT) and control (Placebo) according to the anesthesia technique. In the experimental group, before local infiltration anesthesia was administered, PBMT (a diode laser: 940 nm; continuous mode; 0.5W; 78 J/cm2) was applied perpendicular to the root surface at buccal and palatal area for 60 sec each). In the control group, the laser probe was directed to the mucosa for (buccal and palatal area), but not activated. Evaluation of the pain scores were performed during the access cavity preparation of the pulpotomy treatment using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale. Also, additional anesthesia requirements were assessed for both groups while working on the dentin and pulp

Conditions

Low-level-laser Theraphy; Anesthesia, Local; Molar Incisor Hypomineralization

Outcome Measures

Primary Outcomes (2)

• Evaluating efficacy of anesthesia with using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale

  Anesthesia efficacy was evaluated objectively with the FLACC scale during the cavity preparation. Behavioral parameters were recorded during the cavity preparation (dentin cutting handpiece ) FLACC scale comprises of five sub-parameters. They are Face, Legs, Activity, Crying and Consolability. Each sub-parameter is given a pain score of 0 to 2. So total behavioral pain score range 0-10 as follows: 0 = relaxed and comfortable (no pain); 1-3= mild discomfort; 4-6 = moderate pain; and 7-10 = severe discomfort and/or pain. Success was achieved if patients experienced mild pain or no pain during the preparation of the cavity

  Through study completion, an average of 24 weeks

• Evaluating need of supplementary anesthesia

  The subjects with moderate/higher pain need supplementary anesthesia

  Through study completion, an average of 24 weeks

Study Arms (2)

Photobiomodulation group

EXPERIMENTAL

In the experimental group, before local infiltration anesthesia was administered, PBMT (a diode laser: 940 nm; continuous mode; 0.5W; 78 J/cm2) was applied perpendicular to the root surface at buccal and palatal area for 60 sec each).

Procedure: Photobiomodulation

Placebo Group

PLACEBO COMPARATOR

In the control group, the laser probe was directed to the mucosa for (buccal and palatal area), but not activated.

Procedure: Placebo

Interventions

Photobiomodulation PROCEDURE

In experimental groups, before topical anesthesia, PBMT was applied by utilizing a diode laser (EpiX; Biolase technology, inc., USA) with a continuous wavelength of 940 nm on a 400-μm fiber with only biostimulation properties. In accordance with the recommendations of the device's manufacturer, it was applied using circular motions in a manner as slowly as possible (an average of 33-36 circular movements in 60 s)

Photobiomodulation group

Placebo PROCEDURE

In the control group (placebo), the laser probe was directed to the mucosa for (buccal and palatal area), but not activated, and the sound of the laser device previously recorded on the mobile telephone was played for the same time of experimental group in order to provide similar conditions

Placebo Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of Molar Incisor Hypoplasia (MIH)
• Maxillary permanent first molars with MIH
• Must be the score 3 of MIH (European Academy of Paediatric Dentistry MIH diagnostic criteria

You may not qualify if:

• The teeth showing irreversible pulp pathology (according to the American Association of Endodontics)
• The children who had negative or definitely negative behavior
• Allergy to local anesthetics
• Taking any medication that might affect the anesthetic assessment

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University Faculty of Dentistry

Kocaeli, 41190, Turkey (Türkiye)

Location

Related Publications (3)

• Topcuoglu HS, Akpinar B. The effect of low-level laser therapy on the success rate of inferior alveolar nerve blocks in mandibular molars with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2021 Oct;54(10):1720-1726. doi: 10.1111/iej.13596. Epub 2021 Aug 2.

  PMID: 34241896 BACKGROUND

• Ghabraei S, Chiniforush N, Bolhari B, Aminsobhani M, Khosarvi A. The Effect of Photobiomodulation on the Depth of Anesthesia During Endodontic Treatment of Teeth With Symptomatic Irreversible Pulpitis (Double Blind Randomized Clinical Trial). J Lasers Med Sci. 2018 Winter;9(1):11-14. doi: 10.15171/jlms.2018.03. Epub 2017 Dec 26.

  PMID: 29399304 BACKGROUND

• Menoncin BLV, Portella PD, Ramos BLM, Assuncao LRDS, de Souza JF, Menezes JVNB. Dental anxiety in schoolchildren with molar incisor hypomineralization-A population-based cross-sectional study. Int J Paediatr Dent. 2019 Sep;29(5):615-623. doi: 10.1111/ipd.12503. Epub 2019 May 6.

  PMID: 31009135 BACKGROUND

MeSH Terms

Conditions

Molar Hypomineralization

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 25, 2022
• Study Start: January 11, 2022
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)